Back to results

Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia (IVIRONMAN)

Primary Purpose

Anemia, Iron Deficiency, Delivery Complication

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ferrous sulfate

Iron dextran

About this trial

This is an interventional treatment trial for Anemia, Iron Deficiency focused on measuring Postpartum, iron deficiency anemia, intravenous iron

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Delivery at our institution
Hemoglobin below 9 g/dl in postpartum day 1
Singleton gestation

Exclusion Criteria:

Diagnosis of malabsorptive disorder or history of gastric bypass procedure
Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic anemia, sickle cell, etc.)
Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of NYHA Class III or IV congestive heart failure
Patient has received blood transfusion or there is a plan to transfuse
Lactose intolerance

Sites / Locations

Ashley Salazar

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Oral Iron group

IV Iron group

Arm Description

Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks three times daily. Intravenous placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride.

Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride. Oral placebo will be given by mouth for a total of 6 weeks TID.

Outcomes

Primary Outcome Measures

Hemoglobin Level

hemoglobin in grams per deciliters

Secondary Outcome Measures

Number of Participants With Nausea or Vomiting

feeling sick to vomit or vomit

Myalgia

Generalized muscle pain

Full Information

NCT ID

NCT05047211

First Posted

September 7, 2021

Last Updated

August 4, 2023

Sponsor

The University of Texas Medical Branch, Galveston

1. Study Identification

Unique Protocol Identification Number

NCT05047211

Brief Title

Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia

Acronym

IVIRONMAN

Official Title

A Feasibility Trial of Intravenous Iron vs. Oral Iron Supplementation for the Treatment of Postpartum Anemia (IVIRONMAN)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

October 7, 2021 (Actual)

Primary Completion Date

March 15, 2023 (Actual)

Study Completion Date

April 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Medical Branch, Galveston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

This trial will be a comparative pragmatic open label feasibility randomized controlled trial of oral daily versus IV iron in anemic postpartum patients. Two randomly assigned groups will be compared during the postpartum period: Oral Iron group: Ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks TID. IV placebo in sodium chloride 0.9% 500mL IV infusion will be given before discharge home over 1 hour preceded by placebo test dose IV infusion of 100mL 0.9% sodium chloride. IV Iron group: Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion in 100mL 0.9% sodium chloride. 2.1 Oral placebo will be given by mouth for a total of 6 weeks TID.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Iron Deficiency, Delivery Complication

Keywords

Postpartum, iron deficiency anemia, intravenous iron

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Randomized control trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double blinded placebo controlled clinical trial. We will be using intravenous and oral placebos for each interventions

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Iron group

Arm Type

Active Comparator

Arm Description

Arm Title

IV Iron group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ferrous sulfate

Intervention Description

one tablet 325 milligrams three times a day

Intervention Type

Drug

Intervention Name(s)

Iron dextran

Intervention Description

1000 mg intravenous infusion

Primary Outcome Measure Information:

Title

Hemoglobin Level

Description

hemoglobin in grams per deciliters

Time Frame

6 weeks after delivery

Secondary Outcome Measure Information:

Title

Number of Participants With Nausea or Vomiting

Description

feeling sick to vomit or vomit

Time Frame

up to 6 weeks after delivery

Title

Myalgia

Description

Generalized muscle pain

Time Frame

up to 6 weeks after delivery

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Participant eligibility is based on self-representation of gender identity.

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Delivery at our institution Hemoglobin below 9 g/dl in postpartum day 1 Singleton gestation Exclusion Criteria: Diagnosis of malabsorptive disorder or history of gastric bypass procedure Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic anemia, sickle cell, etc.) Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of NYHA Class III or IV congestive heart failure Patient has received blood transfusion or there is a plan to transfuse Lactose intolerance

Facility Information:

Facility Name

Ashley Salazar

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia

We'll reach out to this number within 24 hrs